MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH; MESH, SURGICAL, POLYMERIC

Model Number	PCO15FX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hair Loss (1877); Pain (1994); Visual Impairment (2138); Depression (2361); No Code Available (3191)
Date of Event	03/24/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, post incisional hernia, the mesh started giving the patient sharp stabbing pains straight away but was told that it was okay.It failed and was stuck in the patient's bowel then more mesh was inserted laparoscopy.The surgeon peel the mesh on the bowels but the pain started again on the patient's bowels.The patient had an operation to reconstruct the abdomen and was found that her bowels were stuck with mesh.The surgeon said "i picked out what i could of the mesh and haven't put any more in".Currently, the patient have an extremely large hernia that nobody wants to touch because of a burst appendix and mesh.It was also reported that this her autoimmune system.She suffered chronic flu symptoms daily, bone and joint pain, hair loss, depression and vision was worse.

• Brand Name: MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 8546763
• Report Number: 9615742-2019-01481
• Device Sequence Number: 11373537
• Product Code: FTL
• UDI-Device Identifier: 10884521179783
• UDI-Public: 10884521179783
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K110663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PCO15FX
• Device Catalogue Number: PCO15FX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 04/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention